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A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's

ConditionHead and Neck Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAll India Institute of Medical Sciences

About this trial

The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 or above and less than 70 years

Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.

Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4

At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)

Disqualifiers

Non squamous histology

Presences of distant metastases

pT1-2 disease and no high risk features

Pathologically N2/N3 disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMRT - adjuvant concurrent CRT/ RT

    Radiation

    IMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics

  • ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphatics

    Radiation

    IMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only \- elimination of regional lymphatics

  • Cisplatin

    Drug

    Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease.

Treatment groups

396 Participants
are divided into 2 treatment groups
Group A: Arm AActive comparator 2 interventions
Group B: Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Regional control

Regional control will be assessed as occurrence of any new lesion in the regional /nearby area over time with the help of radiological imaging (CT/MRI/PET-CT) and clinical examination. will be assessed at 3 months, 6 months, 12 months, 18 months, 24 months

Time frame
2 years

Secondary outcomes

1

Local control

Local control will assess the recurrence within the primary tumor site at its original location. Radiographic assessment (CT/MRI/PET-CT) at 3, 6, 12, 18 and 24 months

Time frame
2 years
2

Disease free survival

assessed as the length of time that a patient survives without any signs and symptoms of the disease and assessment will be done at every 3, 6, 12, 18, 24 months

Time frame
2 years
3

Overall survival

longitudinal assessment every 3, 6, 12, 18, 24 months

Time frame
2 years
4

Acute toxicity

Acute toxicity is the side effects that appear within 90 days after the radiation therapy and will be assessed using RTOG acute toxicity scale with grading from 0 to IV where 0 represents no findings and IV being the worst Findings. Higher values wiill be showing worsening of the condition. it will be scored weekly during radiation.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

All India Institute of Medical Sciences

Lead sponsor

All India Institute of Medical Sciences, Rishikesh

Collaborator

All India Institute of Medical Sciences, Raipur

Collaborator

Jawaharlal Institute of Postgraduate Medical Education & Research

Collaborator

Source ClinicalTrials.gov
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